System for guide catheter control with introducer connector

ABSTRACT

An introducer assembly for introducing a catheter into a patient, includes a sheath having a distal end and a proximal end with a hollow lumen extending between the distal end and proximal end. The assembly also includes a coupler having a distal end operatively coupled to the proximal end of the sheath, the coupler having an internal passage in fluid communication with the hollow lumen. The assembly further includes a connector having a distal end operatively coupled to the coupler proximate the distal end of the coupler.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 14/106,638 entitled SYSTEM FOR GUIDE CATHETER CONTROL WITHINTRODUCER CONNECTOR filed Dec. 13, 2013 and issued as U.S. Pat. No.9,427,562, which claims priority to U.S. Provisional Application No.61/737,092, filed Dec. 13, 2012, entitled SYSTEM FOR GUIDE CATHETERCONTROL WITH INTRODUCER CONNECTOR, both of which are incorporated hereinby reference in its entirety.

BACKGROUND

The present invention relates generally to the field of catheter systemsfor performing diagnostic and/or intervention procedures. The presentinvention relates specifically to a guide catheter control in roboticcatheter system with an introducer connector.

Vascular disease, and in particular cardiovascular disease, may betreated in a variety of ways. Surgery, such as cardiac bypass surgery,is one method for treating cardiovascular disease. However, undercertain circumstances, vascular disease may be treated with a catheterbased intervention procedure, such as angioplasty. Catheter basedintervention procedures are generally considered less invasive thansurgery.

During one type of intervention procedure, a guide catheter is insertedinto a patient's femoral artery through an introducer and positionedproximate the coronary ostium of a patient's heart. A guide wire isinserted into the guide catheter typically through a hemostasis valveand maneuvered through the patient's arterial system until the guidewire reaches the site of the lesion. A working catheter is then movedalong the guide wire until the working catheter such as a balloon andstent are positioned proximate the lesion to open a blockage to allowfor an increased flow of blood proximate the lesion. In addition tocardiovascular disease, other diseases may be treated withcatheterization procedures.

SUMMARY OF THE INVENTION

In accordance with an embodiment, an introducer includes a couplerhaving a distal end configured to operatively couple a sheath and aconnector extending from the proximal end of the coupler. The connectorhas a portion that expands and contracts along a longitudinal axis uponthe application of a force applied to a distal end of the connector.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a hemostasis valve.

FIG. 2 is a schematic view of a robotic catheter control system.

FIG. 3 is an isometric view of a catheter bedside system.

FIG. 4 is an isometric view of a catheter bedside system.

FIG. 5 is an isometric view of a hemostasis valve and guide catheterdrive mechanism.

FIG. 6 is a cross-sectional view a hemostasis valve.

FIG. 7 is a top view of the catheter bedside system of FIG. 2.

FIG. 8 is a side view of the catheter bedside system of FIG. 2.

FIG. 9 is an isometric view of the guide catheter drive mechanism andtrack.

FIG. 10 is a cross sectional view of the track.

FIG. 11 is a top schematic view of the hemostasis valve, guide wire,working catheter, and guide catheter.

FIG. 12 is a rear isometric view of the catheter bedside system.

FIG. 13 is an alternative hemostasis valve and guide catheter drivemechanism.

FIG. 14 is a partial side view of the hemostasis valve and guidecatheter.

FIG. 15 is a partial side view of an alternative guide catheter hub andguide catheter drive mechanism.

FIG. 16 is an isometric view of a quick release for a hemostasis valve.

FIG. 17 is a cross sectional view of a portion of the quick release ofFIG. 16. in an engaged position.

FIG. 18 is a cross sectional view of a portion of the quick release ofFIG. 16. in a disengaged position.

FIG. 19 is a side isometric view of an introducer connector.

FIG. 20 is a side isometric view of the introducer connector of FIG. 19with a movable opening.

FIG. 21 is a side isometric view of a second embodiment of an introducerconnector.

FIG. 22 is a side isometric view of a third embodiment of an introducerconnector.

FIG. 23a is a side isometric view of the introducer of FIG. 21 with abreakaway portion.

FIG. 23b is a side isometric view of the introducer connector of FIG. 21with a breakaway portion in the separated position.

FIG. 24 is a side isometric view of another introducer connector.

FIG. 25 is a side view of another embodiment of an introducer connector.

DETAILED DESCRIPTION OF THE EXAMPLE EMBODIMENTS

Referring to FIG. 1, a Y-connector or hemostasis valve 34 includes avalve body with a first leg 38 having a proximal port adjacent aproximal end 42 and a distal port adjacent a distal end 40. First leg 38includes lumen extending between the proximal end 42 and the distal end40. A valve 162 is disposed adjacent proximal end 42. A rotating luerconnector 48 is rotatably secured to first leg 38 proximate distal end40. Rotating luer connector 48 includes a member 56 configured to berotatably driven by a drive mechanism of a robotic catheter system 10.

Referring to FIG. 2, a robotic catheter system 10 includes a bedsidesystem 12, a work station 14 including a controller 16, a user interface18 and display 20. Bedside system 12 is located adjacent a patient bed22 and an imaging system 24. Imaging system 24 may be any medicalimaging system that may be used in conjunction with a catheter basedmedical procedure (e.g., non-digital x-ray, digital x-ray, CT, MRI,ultrasound, etc.).

In one embodiment, imaging system 24 is a digital x-ray imaging devicethat is in communication with workstation 14. Imaging system 24 isconfigured to take x-ray images of the appropriate area of patientduring a particular procedure. For example, imaging system 24 may beconfigured to take one or more x-ray images of the heart to diagnose aheart condition. Imaging system 24 may also be configured to take one ormore x-ray images during a catheter based medical procedure (e.g.,real-time images) to assist the user of workstation 14 to properlyposition a guide wire, guide catheter, and a working catheter such as astent during a procedure. The image or images may be displayed ondisplay 20 to allow the user to accurately steer a distal tip of a guidewire or working catheter into proper position. As used herein thedirection distal is used to refer to the direction closer to a patientin the intended use of the component and the term proximal is used torefer to the direction further away to a patient in the intended use ofthe component.

Referring to FIG. 3 bedside system 12 includes a guide cathetermechanism 26, a working catheter mechanism 28 and a guide wire mechanism30. In one embodiment, working catheter mechanism 28 and guide wiremechanism 30 are of the type described in U.S. Pat. No. 7,887,549entitled “Catheter System” which is incorporated herein in its entirety.

Referring to FIGS. 3-5 guide catheter mechanism 26 includes a base 32configured to releasably receive a hemostasis valve 34 and a guidecatheter rotational drive 36. Base 32 may include a quick releasemechanism to releasably secure hemostasis valve 34 to base 32. Oneembodiment of a guide catheter quick release is disclosed in U.S.application publication U.S. 2012/0179032 entitled “Remote CatheterSystem With Steerable Catheter” which is incorporated herein in itsentirety.

Hemostasis valve 34 includes a first leg 38 having a distal end 40 and aproximal end 42. A second leg 44 extends from first leg 38 and is influid communication with first leg 38 such that a fluid may beintroduced into a proximate end 46 of second leg 44. Hemostasis valvefirst leg 38 defines a longitudinal axis 50 extending from proximal end42 of first leg 38 to distal end 40 of first leg 38.

The distal end 40 of first leg 38 includes a rotating luer connector 48that is rotatably coupled to distal end 40 of first leg 38. Rotatingluer connector 48 includes an external surface 52 and an internal region54 having a luer female interface to releasably couple a guide catheter.Luer connectors are known in the art and provide a fluid tightconnection between a guide catheter and a hemostasis valve. Luerconnectors are covered by standards such as ISO 594 (including sections594-1 and 594-2) and EN 1707.

In one embodiment external surface 52 of rotating luer connector 48includes a gear 56 that is driven by rotational drive 36. Rotationaldrive 36 includes a drive gear 58 operatively connected to a motor 60.Gear 56 may be integrally formed with rotating luer connector 48 andcoupled with a drive gear 58 for rotational movement of the rotatingconnector.

In another embodiment, gear 56 may be secured to the outer surface ofrotational luer connector 48 such that gear 56 rotates along with therotation of rotational luer connector 48 about longitudinal axis 50 ofthe first leg 38 of hemostasis valve 34.

Gears 56 and 58 may be beveled gears or miter gears to provide directrotation of driven gear 56 from a shaft rotated by motor 60 andextending along an axis 62 perpendicular to longitudinal axis 50 offirst leg 38 of hemostasis valve 34. Referring to FIG. 1, gear 56 isbeveled such that gear teeth 64 extend in a direction toward proximalend 42 and away from distal end 40 of first leg 38. Additionally, in oneembodiment driven gear 56 is located a distance from distal end 40 topermit attachment and removal of a guide catheter from rotational luerconnector 48. Drive gear 58 is positioned below first leg 38 to permiteasy removal of the hemostasis valve 34 from base 32.

Motor 60 may be secured to base 32, such that drive gear 58 is locatedabove a first surface 66 of base 32 and motor 60 is located below anopposing second surface 68 of base 32. First surface 66 being closer tofirst leg 38 than second surface 68 of base 32.

Referring to FIG. 1 FIG. 6 second leg 44 of hemostasis valve 34 has alongitudinal axis 70 extending longitudinally along second leg 44 fromproximate end 46 to a distal end 72 adjacent first leg 38. A second legworking plane is defined by axis 50 of first leg 38 and axis 70 ofsecond leg 44. In one embodiment hemostasis valve 34 is secured to base32 such that the second leg working plane is not perpendicular to thehorizontal as defined by gravity. Rather the second leg working planeforms an acute angle with respect to a vertical plane permitting anoperator access to proximate end 46 of second leg 44. In one embodimentsecond leg working plane may be co-planer with a horizontal plane. Asdiscussed above, hemostasis valve 34 may be releasably coupled to base32 with a quick release that allows removal of hemostasis valve 34 frombase 32.

Referring to FIG. 5, base 32 includes a raised wall 74 extendingupwardly from and perpendicular to surface 66. Wall 74 extends in adirection parallel to axis 50 of hemostasis valve 34, when hemostasisvalve 34 is secured to base 32. Wall 74 is proximate a rear portion 76of base 32 and distal a front portion 78 of base 32. Gear 58 beingintermediate wall 74 and front portion 78 of base 32. A guide member 80is secured to wall 74 and extends in a direction substantially parallelto axis 50 when hemostasis valve 34 is secured to base 32. Guide member80 has a guide portion 82 configured to direct a portion of a guidecatheter prior to the guide catheter entering a sleeve 84.

Referring to FIG. 3 and FIG. 10 a track 86 includes a channel 88. A setscrew 90 or other type of fastener extends through track 86 into channel88 to secure sleeve 84. In one embodiment sleeve 84 includes a firstwall 92 and a second wall 94 and a third wall 96 extending from firstwall 92 forming a cavity 98. An opening 100 is defined as the spacebetween the two free ends of second wall 94 and third wall 96. Inanother embodiment, sleeve 84 may be formed by a single arcuate wallmember having an opening 100. A disposable sterile barrier sleeve suchas a plastic sleeve may be located about track 86 such that when sleeve84 is isolated from track 86. Sleeve 84 may be a single use device anddisposed of once a medical procedure using the sleeve is complete. Inanother embodiment, no sleeve 84 is placed into channel 88, rather asterile barrier may be placed within channel 88 to isolate a guidecatheter from the walls of channel 88. In an alternative embodiment, nosleeve or sterile barrier is employed and track 86 is a single usedevice that is discarded after use and replaced prior to the use of thebedside system with another patient or for another procedure.

Referring to FIG. 7 and FIG. 8 track 86 includes a distal end 102 thatis configured to be located proximate a patient, and an opposingproximal end 104. A track longitudinal axis 106 is defined by thelongitudinal axis of the track 86 extending between proximal end 104 anddistal end 102. In one embodiment track longitudinal axis 106 andhemostasis valve longitudinal axis 50 form an acute angle 108. In oneembodiment angle 108 is preferably between 25 and 45 degrees, and morepreferably between 30 and 45 degrees. In one embodiment angle 108 is 30degrees.

In one embodiment plane track longitudinal axis 106 forms an acute angle112 with a horizontal plane defined by gravity that also represents thehorizontal plane of a bed or procedural surface that a patient lies on.Track longitudinal axis 106 and hemostasis valve first leg longitudinalaxis 50 form a plane 110. In one embodiment plane 110 is at an acuteangle 108 with respect to the horizontal plane. In other embodiments,the angle formed between plane 110 and the horizontal may be an acuteangle different than the angle formed by track longitudinal axis 106 andthe horizontal plane.

Referring to FIGS. 7 and 8 guide catheter mechanism 26 is offset to oneside of track 86, as a result plane 110 is not perpendicular to thehorizontal plane. In one embodiment guide catheter mechanism 26 islocated closer to an operator than track 86. Stated another way, when anoperator operates guide catheter mechanism 26 the operator will becloser to the guide catheter mechanism than the track.

Referring to FIG. 3, in one embodiment, track 86, guide cathetermechanism 26 and cassette 118 may be rotated downwardly about axis ysuch that guide catheter mechanism 26 and cassette 118 are easier toaccess by an operator facing guide catheter mechanism 26 and cassette118. In one embodiment, the vector shown as x is perpendicular to thelongitudinal axis 106 extends through channel 88 and forms an angle 166below a horizontal plane. In one embodiment angle 166 is 15 degreesbelow a horizontal plane as defined by gravity. In one embodiment anoperator is located proximate a first side a patient's bed. A support islocated on one side of the bed typically opposite the first side. Thecassette 118 and guide catheter mechanism 26 is closer to the first sideof the patient's bed than track 86. In this way, the operator orphysician has easy access to the cassette 118 and guide cathetermechanism 26. By tilting the cassette 118 and guide catheter mechanismdownwardly toward the patient's bed such that the portion of thecassette 118 and guide catheter mechanism 26 closer to track 86 ishigher vertically than the portion of the cassette 118 and guidecatheter mechanism 26 that is furthest from track 86. Additionally, bypivoting guide catheter mechanism 26 and cassette 118 from thelongitudinal axis 106 by angle 108, the guide catheter mechanism andcassette 118 is located in a position that allows for access by theoperator and/or physician.

Track 86 is secured to a bedside support 114 and is maintained in afixed position relative to patient bed 22. Bedside support 114 may besecured directly to a side of patient bed 22 or may be secured to afloor mounted support that is either fixed relative patient bed 22 orpositioned on a floor proximate patient bed 22 such that track 86 is ina fixed location with respect to patient bed 22 or to a patient onpatient bed 22 during a catheter based procedure. In one embodiment, theorientation of track 86 may be adjusted with respect to patient bed 22so that angle 112 may be adjusted as well. In another embodiment angle112 may be between ten degrees and forty five degrees and in oneembodiment angle 112 may be thirty degrees.

Referring to FIG. 12 guide catheter mechanism 26 may be secured to alinear actuator 116 to translate guide catheter mechanism along an axisparallel to or co-linear with track axis 106. The linear actuator 116may provide for discrete incremental movement or may provide forcontinuous movement. In one embodiment the linear actuator includes arack and pinion and in another embodiment includes a robotic arm. Linearactuator 116 moves independently of track 86. As discussed above workingcatheter mechanism 28 and guide wire mechanism 30 may be included in acassette 118 that is operatively removably secured to a base member 120.Base member 120 and guide catheter mechanism 26 may be operativelysecured to linear actuator 116 with a support 164, such that guidecatheter mechanism 26, working catheter mechanism 28, and guide wiremechanism 30 are translated together along a linear axis.

The operation of the guide catheter mechanism 26 during a catheterprocedure will now be described using an exemplary embodiment. A patientin need of a catheter based procedure will lie in a supine position onpatient bed 22. An opening in the femoral artery will be prepared forthe introduction of a guide catheter 122.

Track 86 will be positioned relative to the patient such that distal end102 of track 86 is located proximate the femoral artery of the patient.Track 86 is covered with a sterile barrier and a single used sleeve 84is positioned in channel 88. Typically track 86 will be covered with asterile barrier prior to positioning relative to the patient. As sleeve84 is positioned in channel 88 the sterile barrier is placed intochannel 88 such that the sterile barrier provides a guard against anyfluids that may be exposed on sleeve 84 from contacting track 86. Sleeve84 has a distal end 124 and a proximal end 126. Distal end 124 of sleeve84 is located proximal distal end 102 of track 86. In one embodiment,sleeve 84 may have certain geometry to provide for placement withinchannel 88 of track 86 and to facilitate entry and removal of a portionof guide catheter 122.

In one catheter procedure on the heart of a patient, a guide catheter122 of appropriate length is selected based on the size of the patient.Guide catheter 122 has a proximal end 128 and a distal end 130. In oneembodiment, proximal end 128 is first connected to rotating luerconnector 48 of hemostasis valve 34. Distal end 130 is then manuallyinserted into the femoral artery of the patient and positioned such thatdistal end 130 of the guide catheter 122 is located adjacent the ostiumof the heart. It is also contemplated that proximal end 128 of guidecatheter 122 may be connected to rotating luer connector 48 after distalend 130 is positioned adjacent the ostium.

Once guide catheter 122 is properly positioned relative to the patient'sheart, a central portion 132 of guide catheter 122 located outside ofthe patient is placed within sleeve 84 by pushing a central portion 132of guide catheter 122 through opening 100 into cavity 98.

Referring to FIG. 9 and FIG. 11, an entering portion 134 of guidecatheter 122 will be exposed between distal end 102 of track 86 and thepatient. Additionally, a connecting portion 136 adjacent proximal end124 of guide catheter 122 extends outwardly from sleeve 84 and track 86in a direction toward guide catheter mechanism 26. In one embodiment,connecting portion 136 has sufficient length to allow for the guidecatheter hub to be connected to rotating luer 52 and have sufficientlength to bend into track 86. Connecting portion 136 extends outwardlyfrom sleeve 84 at angle between approximately 25 to 45 degrees and 30 inbut may be between 30 and 45 degrees and may be 30 degrees. Guideportion 82 guides guide catheter from support 80 into track 86. Guideportion 82 may include a curved surface to assist in the transition ofthe guide catheter into track 86.

Proximal end 128 guide catheter 122 is connected to rotating luerconnector 48. In one embodiment, proximal end 128 of guide catheter 122is connected to rotating luer connector 48 of hemostasis valve 34 priorto distal end 124 of catheter 122 being inserted into the patient orprior to central portion 132 being positioned within sleeve 84.Hemostasis valve 34 is secured to base 32 with a quick release mechanism138 such that driven gear 56 is engaged with drive gear 58. Driven gear56 located on external surface 52 of rotating luer connector 48 is movedin a direction toward drive gear 58 to engage driven gear 56 with drivegear 58. Quick release 138 is then closed to releasably capturehemostasis valve 34. In an engaged position proximal end 46 of secondleg 44 of hemostasis valve extends away from track 86 and having ahorizontal vector component. Stated another way in a preferredembodiment, second leg working plane defined by axis 50 of first leg 38and axis 70 of second leg 44 does not define a plane that isperpendicular to a horizontal plane defined by gravity or by ahorizontal plane defined generally by the top surface of the patient'sbed 22.

Guide Catheter mechanism 26 is moved linearly by linear actuator 116 toallow proper alignment of proximal end 126 of guide catheter 122 withguide catheter mechanism 26. Guide catheters are typically sold withvarying lengths and selected depending on the size of the patient.However, since the length of the guide catheter required varies frompatient to patient, it may be necessary to adjust the position of thehemostasis valve quick release for each patient. In one embodimenthemostasis valve quick release may be adjusted along an axis parallel totrack axis 106 relative to base 32. In another embodiment, base 32 maybe moved along an axis parallel to track axis 106 to properly positionhemostasis valve 34 so that guide catheter 122 is properly positionedrelative to the patient.

Linear adjustment of hemostasis valve along an axis parallel to trackaxis 106 may be done manually or may be controlled by user interface 18at work station 14 that is typically remote from bedside system 12. Workstation 14 communicates with bedside system through a wireless or wiredconnection. In this embodiment, an operator manipulates user interface18 such as a joy stick or touch screen to provide a control signal to alinear actuator motor to move base 32 relative to track 86.

Once guide catheter 32 is secured to hemostasis valve 34 and hemostasisvalve 34 is secured to base 34 with quick release 138 a guide wire 140and/or working catheter 142 is introduced into the proximal end 42 offirst leg 38. Proximal end 42 of first leg 38 includes a valve member162 such as a Tuohy Borst adapter. Tuohy Borst adapters are known in theart and operate to adjust the size of the opening in proximal end 42 offirst leg 38 of hemostasis valve 34 to minimize the risk that fluids mayexit the proximal end 42 of first leg 38. Other types of adapters knownin the art may also be used with hemostasis valve 34 to adjust the sizeof the opening in proximal end 42 of first let 38.

During a catheter procedure it may be necessary to reseat distal end 124of guide catheter 122 within the ostium of the patient. An operator mayrotate guide catheter 122 by providing a control signal to motor 60 torotate drive gear 58 in a clockwise or counterclockwise direction. As aresult driven gear 56 rotates causing rotation of rotating luerconnector 48 and rotation of guide catheter 122. In addition to arequirement to rotate guide catheter 122 it may also be necessary duringa catheter procedure to move guide catheter 122 along track axis 106 toproperly position distal end 124 of guide catheter 122. Work station mayalso include a user interface such as a joy stick, button, touch screenor other user interface to control a linear actuator to move guidecatheter mechanism 26 in a direction substantially parallel to trackaxis 106. Movement in a first direction in parallel to track axis willresult in movement of guide catheter 122 further into the patient andmovement of the linear translator in an opposing second direction willresult in movement of guide catheter 122 outwardly from the patient.

If an operator wishes to remove guide catheter 122, working catheter 142and/or guide wire 140 during a catheter procedure, the operator releasesquick release 138 and removes hemostasis valve 34 along with guidecatheter 122 and working catheter 142 and/or guide wire 140. Centralportion 132 of guide catheter 122

Working catheter 142 and guide wire 140 may be removed from theirrespective working catheter mechanism 28 and guide wire mechanism 30 asdescribed in U.S. Pat. No. 7,887,549. Once guide catheter 122, 140hemostasis valve 34, working catheter 142 and guide wire 140 are removedfrom guide catheter mechanism 26, working catheter mechanism 28 andguide wire mechanism 30 an operator may manipulate guide catheter 122,working catheter 142 and guide wire 140 manually.

Referring to FIG. 13 an alternative embodiment of a drive for rotationalluer connector includes a motor 144 rotating a first pulley 146 drivinga belt 148 such as a timing belt. Belt 148 is connected to the outersurface 150 of a pulley 152 about the outer surface 150 of a rotationalluer connector 156. First pulley 146 may include a plurality of teeththat mesh with ribs on belt 148 and the outer surface 150 of rotationalluer connector 154 also include a plurality of teeth that mesh with ribson belt 148. In this manner control of motor 144 allows for controlledrotation in a clockwise and counterclockwise of rotational luerconnector 156 thereby rotating guide catheter 122 attached thereto. Inone embodiment pulley 152 and bevel gear 56 are integrally formed withthe outer surface of rotating luer connector. However, it is alsocontemplated that a collet having an outer surface defining a pulley orbevel gear may be secured to the outer surface of rotating luerconnector.

Referring to FIG. 14, in another embodiment, a luer extension member 158may act to connect proximal end 128 of guide catheter 122 to rotatingluer connector 48. Luer extension member 158 may include an outersurface having a gear 160 or pulley member to be operatively connectedto the rotational drive motor 60 via drive gear 58. In this embodiment,the rotational drive motor is operatively coupled to the outer surfaceof luer extension member and not directly to the outer surface of therotating luer connector. This permits the use of presently availablecommercially available hemostasis valves. Additionally in a furtherembodiment a luer extension member may include a rotating portion suchthat the distal end of the hemostasis valve need not have a rotationalluer connector but rather include a non-rotational luer connector.Extension 158 includes a female luer connector on the distal end toremovably receive a male luer fitting on a guide catheter. Extension 158also includes a male luer connector on the proximal end that isremovably received within a female luer connector of a rotatingconnector on a Hemostasis valve. Note that in one embodiment, gear 160is a beveled gear with teeth facing the proximal end.

Referring to FIG. 15 in another embodiment, a hub of guide catheter 122may have gear formed therewith or attached thereto to connect to arotating luer of hemostasis valve 34.

Referring to FIG. 19 an introducer 300 includes a sheath 302 having adistal end 304 and a proximal end 306. Sheath 302 is a tubular shaftthat is coupled in fluid communication with a coupler 308 at proximalend 306 of sheath 302. Coupler 308 includes a distal end 312 having afunnel or frusto conical shape member 310 providing a transition betweencoupler 308 and the proximal end 306 of sheath 302. Coupler 308 includesa proximal end 314 provide with a hemostasis valve 316 to provide afluid tight seal for a guide catheter, working catheter such as aballoon and stent, and/or a guide wire. Coupler 308 also includes a sideport 318 that is in fluid communication with sheath 302 through aninterior of coupler 308. Side port 318 allows for introducing a flushingsolution such as a saline solution, or a contrast agent or medicationinto the vein through sheath 302. Side port 318 may also be used towithdraw material such as blood from the patient's vein. Coupler 308also includes a disk engagement member 320 that includes an opening 322through which a suture may secure coupler 308 to a patient's skin tostabilize coupler 308 relative to the patient. Disk engagement member320 may also provide a connector to a support that is located on oradjacent to a patient to stabilize coupler 308.

Referring to FIG. 19 and FIG. 20 an introducer connector 324 isreleasably secured to proximal end 314 of coupler 308. In oneembodiment, introducer connector 324 includes a distal end 326 isreleasably secured to proximal end 314 adjacent to hemostasis valve 316in such a manner that hemostasis valve 316 is not blocked. Introducerconnector 324 includes a body 328 that is funnel shaped or frustoconically shaped and configured to guide a guide catheter, workingcatheter or guide wire into coupler 308. Body 328 includes a proximalopening 330 through which guide catheter 122 extends.

Guide catheter 122 that extends from track 86 or sleeve 84 will enteropening 330 and exit through a bottom opening that is adjacenthemostasis valve 316. In one embodiment proximal opening 330 of body 328is located proximate to a distal end 332 of track 86 such that there isa distance 334 between distal end 332 of track 86 and opening 330. Aspatient P moves relative to track 86 the distance 334 will change. Ifdistance 334 is too great guide catheter 122 may begin to buckle priorto entering coupler 308. The term buckle or buckling as used hereinmeans that guide catheter begins to take a non-linear shape without aportion bending over on itself that would prohibit fluid and/or aworking catheter from being extended through the guide catheter. Theterm kink or kinking as used herein means that a portion of the guidecatheter is bent over on itself sufficiently such that the shape of theguide catheter inhibits movement of a working catheter within the guidecatheter.

When a patient moves relative to the distal end 332 of track 86 guidecatheter may begin to buckle. The inner surface of introducer connector324 acts to direct guide catheter toward introducer coupler 308 withoutkinking as guide catheter enters opening 314. In one embodiment, opening330 of introducer connector 324 extends beyond a terminal end 332 oftrack 86 in a direction away from introducer 308. In this embodiment,although introducer connector 324 is not connected to track 86, there isno portion of guide catheter 122 that is exposed between track 86 andcoupler 308. In this configuration, distal end 332 track 86 may move ina fore aft direction away from hemostasis valve 316 while remainingwithin the interior of introducer connector 324.

Referring to FIG. 20 introducer coupler 308 includes a movable topportion 334 proximate opening 310. Movable top portion 334 includes anumber of overlapping floating disks 336 that allow the disks to movefrom side to side as illustrated with arrows 340. Though floating disksmay be movable in any vector direction in a plane defined by the opening330. Top portion 334 allows guide catheter 122 to extend through acentral opening 338 while keeping the interior of introducer connector324 covered.

Referring to FIG. 21 a connector 342 is operatively secured to proximalend 314 of coupler 308 and a distal end 332 of track 86. Connector 342includes an accordion style body 344 that allows the connector 342 tobecome longer and shorter as the patient moves relative to track 86. Inthis way the accordion folds collapse or expand to permit connector 342to have a greater or lesser distance.

Referring to FIG. 22 in another embodiment, a connector 346 includestelescoping members 348 with one of the telescoping members operativelysecured to proximal end 314 of coupler 308 and another of thetelescoping members operatively secured to distal end 332 of track 86.The telescoping members moving relative to one another to allow thedistance between the patient and the track to vary, while stillmaintaining a continuous connection between the coupler 308 ad track 86.The continuous connection provides a path for guide catheter 122 thatavoids buckling and/or kinking. Telescoping connector may include two ormore telescoping members.

Referring to FIG. 23 and FIG. 24 another embodiment of accordionconnector 342 includes a breakaway portion 350 that separates a firstportion 352 of accordion connector 342 from a second portion 354 ofaccordion connector. If accordion connector 342 is stretched too farinstead of exerting a force on introducer 300 that could result inintroducer being pulled away from the patient. Breakaway portion 350,may be formed from a frangible region that is designed to fracture upona predetermined force. Alternatively, a medically safe adhesive may beused that would permit separation of the first portion 352 from thesecond portion 354 upon the exertion of a predetermined force. Inanother embodiment, a hook and loop connector such as Velcro may be usedto provide a breakaway connection at the interface between the firstportion 352 and second portion 354 forming breakaway portion 350. In afurther embodiment, magnetic members may be located at the interfacebetween first portion 352 and second portion 354 to provide a connectionbetween first portion 352 and second portion 354 until a predeterminedforce is applied to the connector as represented by vector directions360, 362.

FIG. 23a illustrates a connector 342 with the breakaway portion 350still in a connected or in a non-separated position. FIG. 23billustrates a connector 342 with the breakaway portion 350 in theseparated position.

While breakaway portion 350 may be located in a center location betweena proximal end 356 and a distal end 358. However breakaway portion 350may be located adjacent one or both of proximal end 356 and distal end358. In an alternative embodiment, one of the proximal end 356 anddistal end 358 may have a breakaway connection with distal end 332 oftrack 86 or proximal end 314 of coupler 308. In another embodiment, thebreakaway connection between connector 342 and the track and/or thecoupler 308 may be friction connection such that once a predeterminedforce is applied to the friction connection, connector 342 will separatefrom track 86 and/or coupler 308. While the examples provided for abreakaway connection was described with connector 342, a breakawayfeature may be added to other connection members operatively connectingcoupler 308 or an introducer sheath 300 with a track 86 or any otherportion of a robotically controlled catheter system.

In another embodiment, connector 342 may have sufficient flexibilitythat upon a predetermined compressive force applied to the distal endand proximal end of connector 342, connector 342 buckles ensuring thatthere the pressure applied to the introducer sheath 300 does not exceeda predetermined force when the track is moved toward the coupler 308and/or the patient.

Referring to FIG. 24 in another embodiment a connector 364 includes ahousing forming an inverted U shape channel to guide the guide catheter122 into coupler 308. Other shapes are also contemplated such as a Cshaped channel. Connector 364 may be secured to distal end 332 of track86 or may be secured to proximal end 314 of coupler 308, or may besecured to both track 86 and coupler 308. Connector 364 may also have abreakaway connection and/or sufficient flexibility to bend if track 86is moved toward coupler 308.

Referring to FIG. 25 in a further embodiment a connector 366 includes afirst portion 368 and a second portion 370 operatively coupled togetherwith an expanding member 372. In a neutral position, first portion 368and second portion 370 are separated by a distance that providessufficient guidance to guide catheter such that it will not buckle orbend. Expanding member 372 has a first leg 374 coupled to first portion368 and a second leg 376 coupled to second portion 370. Expanding memberallows first portion 368 and second portion 370 to move toward and awayfrom one another as track 86 moves toward and away from the patient.Expanding member 372 may have a spring bias to bias the members back tothe neutral position. Additionally, expanding member 372 may have abreakaway portion at or proximate pivot 380 that allows either first leg374 to separate from second leg 376 upon the exertion of a force greaterthan a predetermined force in vector direction 378. It is alsocontemplated that expanding member may have a breakaway portion atpivots 380 and/or 832 where expanding member connects to first portion368 and second portion 370 respectively.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only. The construction and arrangements, shown in thevarious exemplary embodiments, are illustrative only. Although only afew embodiments have been described in detail in this disclosure, manymodifications are possible (e.g., variations in sizes, dimensions,structures, shapes and proportions of the various elements, values ofparameters, mounting arrangements, use of materials, colors,orientations, etc.) without materially departing from the novelteachings and advantages of the subject matter described herein. Someelements shown as integrally formed may be constructed of multiple partsor elements, the position of elements may be reversed or otherwisevaried, and the nature or number of discrete elements or positions maybe altered or varied. The features described herein may be combined inany combination and such combinations are contemplated. The order orsequence of any process, logical algorithm, or method steps may bevaried or re-sequenced according to alternative embodiments. Othersubstitutions, modifications, changes and omissions may also be made inthe design, operating conditions and arrangement of the variousexemplary embodiments without departing from the scope of the presentinvention.

What is claimed is:
 1. A catheter introducer comprising: a couplerhaving a distal end configured to operatively couple to a sheath andhaving a proximal end; a connector extending from the proximal end ofthe coupler, the connector having a distal end, a proximal end and abody portion between the distal end and the proximal end with anaccordion shape that expands and contracts along a longitudinal axisupon the application of a force to the distal end of the connector;wherein the connector includes a breakaway portion that separates theconnector into a first portion and a second portion upon the applicationof a force along the longitudinal axis greater than a predeterminedforce; wherein the breakaway portion is located at a center pointbetween the distal end of the connector and the proximal end of theconnector.
 2. The catheter introducer of claim 1, wherein the breakawayportion includes a frangible portion intermediate the proximal end andthe distal end of the connector.
 3. The catheter introducer of claim 1,wherein the breakaway portion includes an adhesive.
 4. The catheterintroducer of claim 1, wherein the breakaway portion includes a hook andloop connector.
 5. The catheter introducer of claim 1, wherein thebreakaway portion includes a magnetic member.
 6. The catheter introducerof claim 1, wherein the breakaway portion includes a frictionconnection.